Document Center's Standards Forum - Page 146 of 154 - A Review of New Standards and Questions Standards Users Have

BS EN 60601-1, Medical electrical equipment, General requirements for basic safety and essential performance, one of the essential Medical Device Standards

BS EN 60601-1:2006 is one of the essential standards to meet the requirements of the Medical Device Directive for sales of Medical Devices in the European Union. Entitled “Medical electrical equipment. General requirements for basic safety and essential performance,” the standard is identical in content to the IEC 60601-1 Edition 3.0 from 2005.

BS EN 60601-1 is for intended for use by manufacturers, regulation bodies, independent certification bodies and professional users and beneficiaries of medical electrical equipment.

The standard applies to medical electrical equipment intended to be used in the diagnosis, treatment, or monitoring of a patient. It focuses on the basic safety and essential performance of medical electrical equipment and medical electrical systems.

The standard is one of a group of standards in the 60601 series. For a complete listing of the IEC 60601 series documents, here is our Document Center page with the complete listing – http://www.document-center.com/iec_60601.cfm.

And here is a link to our page on all the documents that are part of the harmonized standards list for the Medical Device Directive.

You’ll find both pages useful in identifying the documents you need in order to meet Medical Device regulations globally. The standards are all available from Document Center Inc. on our website, www.document-center.com. Or call us (650-591-7600), fax us (650-591-7617) or send us an email (info@document-center.com). Your questions and comments are always welcome.

AAMI TIR12 2010 Edition, for Reusable Medical Devices, is a top-seller at Document Center Inc.

AAMI TIR12, 2010 Edition, titled “Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers,” is one of the best selling new releases here at Document Center Inc.

This technical information report (TIR) covers design considerations that medical device manufacturers need to consider when developing products that need to be safely and effectively reprocessed. It also provides information on decontamination, cleaning, disinfection, and sterilization processes commonly used in health care facilities. This means that manufacturers can validate reprocessing procedures that can be recommended to and performed adequately in health care facilities. Labeling recommendations and information on applicable regulations are also provided in the TIR, as well as a bibliography and other informative annexes.

Please note: An AAMI TIR like this one is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board.

The document, and all AAMI publications, are available from Document Center Inc. at our website, www.document-center.com. Or contact us via phone (650-591-7600), fax (650-591-7617), or email (info@document-center.com). We’ll be happy to help you with all your standards requirements.

New EIA 649 Revision B, “National Consensus Standard for Configuration Management”

The new EIA-649 Revision B titled “National Consensus Standard for Configuration Management” has just been released by TechAmerica, the organization previously known as GEIA (Government Electronics Industry Association).

Configuration Management (CM) focuses on establishing and maintaining consistency of a system or product’s performance and its functional and physical attributes with its requirements, design, and operational information throughout its life.

This standard defines five CM functions and their underlying principles. The functions are detailed in Section 5. The principles, highlighted in text boxes, are designed to individually identify the essence of the related CM function, and can be used to collectively create a checklist of criteria to evaluate a CM program.

In describing each CM function and its principles, this standard utilizes neutral Configuration Management terminology, while also providing equivalent terms, that have historically been used in various product environments. There is no intent to express preference for any particular set of terminology.

Similarly, this standard uses a neutral set of names for the phases of a product’s life cycle, which are generic enough to be easily mapped to the myriad of different life cycle models in use. Table 1 illustrates some of the aliases for each phase name and identifies characteristics that apply in each one.

Regardless of the titles chosen for these phases, or whether the product is a facility, software, an airplane or a machine screw, at some time in its history a product will go through all or most of these phases. The phases can have considerable overlap, or the sequence of the phases might change or be repeated, e.g., for product improvements and enhancements. Approved configurations of a product can be in the build, distribution, operation, and disposal phases simultaneously, and changes to those configurations may occur during all life cycle phases.

Appropriate application of CM functions enables a user of this standard to plan and implement a CM program for a product, project, or enterprise. The degree to which each of the CM principles applies to a product varies over the product’s life cycle. Some principles do not apply during every phase of the product’s life cycle, e.g., configuration verification and audit principles are not applicable in the conception or definition phases. The degree of rigor and techniques used in implementing CM is commensurate with the type of product and its application environment as defined by program requirements.

The EIA-649 Revision B and all TechAmerica standards are available from Document Center Inc. at our website, www.document-center.com. You can also order via phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Questions are always welcome.

ICS (International Classification for Standards) Codes can help you identify the standards you need

The ICS (International Classification for Standards) Codes are intended to serve as a structure for cataloging standards by subject area. It is similar to the Dewey Decimal system for books in the library. They’re used by standards bodies at the International Level (ISO and IEC), the regional level (CEN and CENELEC in Europe) and at the national level (ASTM International for example). Understanding the ICS schema can help you find the standards you need to maintain the use of best practices in your organization.

The scheme is made up of 3 levels, each divided by a period. The first level is a two digit number that specifies one of forty specific areas of standardization. Some examples are 11 (for Health Care Technology), 25 (for Manufacturing Engineering) and 29 (Electrical Engineering).

Each of these area is then divided into 392 groups for level 2, this time a three digit number. So for Health Care Technology, the 11.040 covers Medical Equipment, 11.060 is for Dentistry, and 11.080 is for Sterilization and disinfection. For section 25, 25.040 is Industrial automation systems, 25.060 is Machine tool systems, and 25.200 is Heat treatment. And in section 29, 29.020 is Electrical engineering in general, 29.030 is Magnetic materials, and 29.045 is Semiconducting materials.

Many of these level two designations still are rather broad, so there is a possible level three (for 144 of the 392 level two groups), again separated by a period. Some examples would be 11.040.40, Implants for surgery, 25.040.30, Industrial robots, Manipulators, or 29.060.01, Electrical wires and cables in general.

You can find the documents you need by drilling down using the links to StandardsCatalog.com above which direct you to lists sorted by the ICS Code numbers. Or you can use the references in StandardsCatalog.com to specific documents like ASTM B633 and use the link found towards the bottom of the page in the section “To find similar documents by classification.” In the case of ASTM B633, the ICS Code is 25.220.40 (Metallic coatings).

Should you find documents you like to purchase, they are available from us at our www.document-center.com website. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Remember, we’re happy to answer any questions you might have about this or any standards-related topic.

New ASTM A484/A484M 2011 Edition for Stainless Steel is now available

The new 2011 Edition of ASTM A484/A484M is now available from Document Center Inc. Titled “Standard Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings,” the specification is widely used for bars, shapes, forgings, and billets or other semi-finished materials, except wire, for forging.

It covers stainless steel in the following conditions: (1) hot-worked; (2) hot-worked and annealed; (3) hot-worked, annealed and cold-worked; or (4) hot-worked, annealed, and heat-treated. Product analysis tolerances are required to conform to the required chemical compositions of carbon, manganese, phosphorus, sulfur, silicon, chromium, nickel, molybdenum, titanium, cobalt, columbium, tantalum, copper, aluminum, nitrogen, tungsten, vanadium, and selenium.

The materials covered are heat treated and austenitic stainless steels and austenitic-ferritic grades. It is expected that they will be furnished in the solution annealed condition. Additionally, conformance to the required values of temperature, permitted annealing procedure, quenching, and rapid cooling are specified.

The following ASTM metal standards are referenced in this document:

ASTM-A262 Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels

ASTM A276, Standard Specification for Stainless Steel Bars and Shapes

ASTM A314, Standard Specification for Stainless Steel Billets and Bars for Forging

ASTM A370 Test Methods and Definitions for Mechanical Testing of Steel Products

ASTM A473, Standard Specification for Stainless Steel Forging

ASTM A479/A479M, Standard Specification for Stainless Steel Bars and Shapes for Use in Boilers and Other Pressure Vessels

ASTM A480/A480M Specification for General Requirements for Flat-Rolled Stainless and Heat-Resisting Steel Plate, Sheet, and Strip

ASTM A555/A555M Specification for General Requirements for Stainless Steel Wire and Wire Rods

ASTM A564/A564M, Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes

ASTM A565/A565M, Standard Specification for Martensitic Stainless Steel Bars for High-Temperature Service

ASTM A582/A582M, Standard Specification for Free-Machining Stainless Steel Bars

ASTM A638/A638M, Standard Specification for Precipitation Hardening Iron Base Superalloy Bars, Forgings, and Forging Stock for High-Temperature Service

ASTM A700 Practices for Packaging, Marking, and Loading Methods for Steel Products for Shipment

ASTM A705/A705M, Standard Specification for Age-Hardening Stainless Steel Forgings

ASTM A751 Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products

ASTM A831/A831M, Standard Specification for Austenitic and Martensitic Stainless Steel Bars, Billets, and Forgings for Liquid Metal Cooled Reactor Core Components (Withdrawn 2005)

ASTM E112 Test Methods for Determining Average Grain Size

ASTM E139 Test Methods for Conducting Creep, Creep-Rupture, and Stress-Rupture Tests of Metallic Materials

The ASTM A484/A484M and all ASTM standards can be purchased from Document Center Inc. at our website, www.document-center.com, in both paper and pdf format. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Comments and questions are welcomed.

New AMS-S-8802 Revision C covers fuel resistant sealants

AMS-S-8802, Sealing Compound, Temperature Resistant, Integral Fuel Tanks and Fuel Cell Cavities, High Adhesion, has just been released as Revision C, dated 3/28/2011. This important standard covers temperature resistant, two component synthetic rubber compounds of the polysulfide type for sealing and repairing integral fuel tanks and fuel cell cavities. It is intended for continuous service use in the temperature range from -65 to +250 °F (-54 to 121 °C).

This sealing compound has been used typically for fuel tank sealing, cabin pressure sealing, and aerodynamic smoothing, but usage is not limited to such applications. It can be used for faying surface sealing, for wet-installation of fasteners, for overcoating fasteners, and for sealing joints and seams. The sealing compound can be used in fuel areas as well as in non-fuel areas. It may in some cases be used as a non-structural adhesive. It cures at room temperature and the cure can be accelerated by higher temperatures.

The document specifies two types of sealing compounds. One is based on Dichromate Cured Sealant Material with a dichromate curing agent. The other is Manganese Dioxide Cured Sealant Material with a manganese dioxide curing agent. Each of the two types is further broken down into classes A, B and C.

AMS-S-8802 Revision C replaces the AMS-S-8802 Revision B from 2005. The document was formerly published as the military specification MIL-S-8802. Copies of both documents, and all AMS and all available military specifications and standards, can be purchased from Document Center Inc. Use our website, www.document-center.com, or phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) us your order. Our staff is happy to help you both with orders and with questions. And consider us for monitoring services as well.

MIL-STD-883 H – The DoD’s top standard for Microcircuits — Plus a list of other relevant standards

MIL-STD-883 Revision H, entitled “Test Method Standard – Microcircuits,” is Document Center’s all-time best selling military standard. It provides approximately 700 pages of tests for microelectronic devices suitable for use within Military and Aerospace electronic systems. It includes basic environmental tests to determine resistance to deleterious effects of natural elements and conditions surrounding military and space operations; mechanical and electrical tests; and workmanship and training procedures.

Revision H was released on 2/26/2010 and compliance with the standard was required by 9/30/2010. Usage of the standard is mandated as part of a contract with the U.S. government.

The document is intended to be used in conjunction with several other major military documents:
MIL-PRF-19500 – Semiconductor Devices, General Specification For.
MIL-PRF-38534 – Hybrid Microcircuits, General Specification For.
MIL-PRF-38535 – Integrated Circuits (Microcircuits) Manufacturing, General Specification For.
MIL-STD-1835 – Electronic Component Case Outlines.
MIL-HDBK-217 – Reliability Prediction of Electronic Equipment.
MIL-HDBK-505 – Definitions of Item Levels, Item Exchangeability, Models, and Related Terms.

There are also references to a number of industry standards that are basic to any standard library for electronic devices:

ISO 14644-1 – Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanliness.
ISO 14644-2 – Cleanrooms and Associated Controlled Environments – Part 2: Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1.
IPC-T-50 – Terms and Definitions for Interconnecting and Packaging Electronic Circuits.
ANSI/NCSL Z540.3 – Requirements for the Calibration of Measuring and Test Equipment, General Requirements
ANSI/J-STD-004 – Requirements for Soldering Fluxes
ANSI/J-STD-005 Requirements for Soldering Pastes
ANSI/J-STD-006 – Requirements for Electronic Grade Solder Alloys and Fluxed and Non-fluxed Solid Solders for Electronic Soldering Applications
IPC/EIA/JEDEC J-STD-002 Solderability Tests for Component Leads, Terminations, Lugs, Terminals and Wires.
EIA/JESD 22-B116 Wire Bond Shear Test
EIA/JESD 78 IC Latch-up Test.
EIA-557 Statistical Process Control Systems.
ASTM E263 – Standard Test Method for Measuring Fast-Neutron Reaction Rates by Radioactivation of Iron.
ASTM E264 – Standard Test Method for Measuring Fast-Neutron Reaction Rates by Radioactivation of Nickel.
ASTM E265 – Standard Test Method for Measuring Reaction Rates and Fast-Neutron Fluences by Radioactivation of Sulfur-32.
ASTM E666 – Standard Practice for Calculating Absorbed Dose from Gamma or X-Radiation.
ASTM E668 – Standard Practice for Application of Thermoluminescence-Dosimetry (TLD) Systems for Determining Absorbed Dose on Radiation Hardness Testing of Electronic Devices.
ASTM E720 – Standard Guide for Selection and Use of Neutron Sensors for Determining Neutron Spectra Employed in Radiation-Hardness Testing of Electronics.
ASTM E721 Standard Method for Determining Neutron Energy Spectra with Neutron-Activation Foils for Radiation-Hardness Testing of Electronics.
ASTM E722 – Standard Practice for Characterizing Neutron Energy Fluence Spectra in Terms of an equivalent Monoenergetic Neutron Fluence for Radiation-Hardness Testing of Electronics.
ASTM E801 Standard Practice for Controlling Quality of Radiological Examination of Electronic Devices.
ASTM E831 Standard Test Method for Linear Thermal Expansion of Solid Materials by Thermomechanical Analysis
ASTM E1249 – Minimizing Dosimetry Errors in Radiation Hardness Testing of Silicon Electronic Devices.
ASTM E1250 – Standard Method for Application of Ionization Chambers to Assess the Low Energy Gamma Component of Cobalt 60 Irradiators Used in Radiation Hardness Testing of Silicon Electronic Devices.
ASTM E1275 – Standard Practice for Use of a Radiochromic Film Dosimetry System.
ASTM F458 – Standard Practice for Nondestructive Pull Testing of Wire Bonds.
ASTM F459 – Standard Test Methods for Measuring Pull Strength of Microelectronic Wire Bonds.
ASTM F526 – Standard Test Method for Measuring Dose for Use in Linear Accelerator Pulsed Radiation Effects Tests.
ASTM F1892 – Standard Guide for Ionizing Radiation (Total Dose) Effects Testing of Semiconductor Devices.
ASTM C177 – Standard Test Method for Steady-State Heat Flux Measurements and Thermal Transmission Properties by Means of the Guarded Hot-Plate Apparatus.
ASTM C518 – Standard Test Method for Steady-State Heat Flux Measurements and Thermal Transmission Properties by Means of the Heat Flow Meter Apparatus.
ASTM D150 – Standard Test Methods for A-C Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulating Materials.
ASTM D257 – Standard Test Methods for D-C Resistance or Conductance of Insulating Materials.
ASTM D1002 – Standard Test Method for Strength Properties of Adhesives in Shear by Tension Loading (Metal-to-Metal).
ASTM D3850 – Standard Test Method for Rapid Thermal Degradation of Solid Electrical Insulating Materials By Thermogravimetric Method (TGA).

The MIL-STD-883, both the current Revision H and previous editions, as well as the other standards noted above, are all available from Document Center Inc. Use our website, www.document-center.com, or phone (650-591-7600), fax (650-591-7617) or email us (info@document-center.com). Any questions or comments you may have are welcome.

ISO/TS 16949 – Quality in the Automotive Industry

When ISO 9001, “Quality management systems — Requirements” was first released in 1987, it provided a platform on which to build a verifiable quality program in any business. But over time, specific industries wanted to tailor the requirements to suit their particular needs. Thus in 1999, ISO/TS 16949, “Quality management systems — Particular requirements for the application of ISO 9001 for automotive production and relevant service part organizations,” was issued.

The TS in the document number stands for Technical Specification. This is a normative specification representing a level of technical consensus within an ISO committee. It requires a consensus vote accepted by 66% of the committee members, rather than the 75% needed to create an ISO standard.

The current 2009 edition of the document includes the text of the ISO 9001:2008, with the paragraphs of the standard in boxed sections. When needed, there is additional text providing additional commentary and requirements. The convention in the document is that the word “shall” indicates a requirement. The word “should” indicates a recommendation. Paragraphs marked “NOTE” are for guidance in understanding or clarifying the associated requirement.

ISO/TS 16949:2009 also includes an Appendix A, which covers Control Plans. This includes both Phases of the control plan and Elements of the control plan.

The document has the support, and is copyrighted by, not only ISO but also ANFIA, FIEV, SMMT, VDA, and the companies Chrysler, Ford Motor Company, General Motors Corp., PSA Peugeot Citroen, and Renault. It was written with the assistance of the International Automotive Task Force.

For automotive manufacturers and their supply chain, the ISO/TS 16949 remains a critical document for compliance with quality requirements in this industry. The document, and all ISO standards, can be purchased from Document Center Inc. at our website, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Your questions and comments are welcome.

Human Factors for Medical Devices – IEC 62366 and ANSI/AAMI HE75

Do you need help in finding the best practices guidance in medical device human factors engineering? With the focus of good design being expanded to the entire product life cycle, the issue of insuring adequate medical device usability has taken on new importance. Here at Document Center Inc. our customers have been relying on two standards for this – ANSI/AAMI 75 and IEC 62366.

Human Factors Engineering (HFE) is a new and separate discipline within the medical device industry. It has evolved due to the high concentration of medical device incident reports and recalls involving use error. HFE includes all aspects of a device that users interact with when operating the product. It considers the interaction with the device by operators, maintainers, cleaners, caregivers, and patients. By providing adequate labeling, instruction, and ease of use, manufacturers can reduce use-associated risk.

IEC 62366 Edition 1.0 from 2007, “Medical devices – Application of usability engineering to medical devices,” focuses on the process of analysis, evaluation, and testing methods for developing safe and usable medical devices. It aims to improve usability by reducing design-induced error. Simply stated, IEC 62366 covers human factors design process — what needs to be done and when.

One important aspect in using the standard is the presumption of reduction of risk as defined in ISO 14971. If the usability engineering process detailed in the standard and the acceptance criteria documented in the usability validation plan have both been met, then the residual risks associated with usability of a medical device are considered to be acceptable, unless there is objective evidence to the contrary.

It is my understanding that if you already meet the IEC 60601-1-6, you have most of the requirements of the IEC 62366 already achieved. The document has been adopted for use in Europe as EN 62366: 2008.

ANSI/AAMI HE75-2009, “Human Factors Engineering—Design of Medical Devices,” covers the principles of HFE. The standard provides detailed human factors engineering design guidance, examples, checklists, and case studies. With 445 pages, and extensive illustrations, it is considered an encyclopedia of HFE for specific situations. It covers all aspect of design, from basic human skills and abilities to post-market issues. The standard is a powerful tool in all stages of the design life cycle.

These standards can all be purchased from Document Center Inc. at our website, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). As always, questions and comments are welcome.

Use of BS EN 10204 for compliance with the Pressure Equipment Directive (97/23/EC)

BS EN 10204:2004, titled Metallic materials, Types of inspection documents, was published in support of the Directive for Pressure Equipment (97/23/EC). This New Approach Directive allows for self-certification of compliance with European Regulations. By following the EN standard when doing business in Europe, one can be assured of meeting the requirements of the Directive. But what exactly is required?

This EN Standard specifies the different types of inspection documents supplied to the purchaser, in accordance with the requirements of the order, for the delivery of all metallic products, e.g. plates, sheets, bars, forgings, castings, whatever their method of production. It may also apply to non-metallic products.

But the document itself does not contain any inspection directions. Indeed, it must be used in conjunction with the product specifications which specify the technical delivery conditions of the order itself.

So what exactly does it specify?

The document first of all defines a series of document type designations, like Type 2.1, Declaration of compliance with the order, and 2.2, Test report. For each document type, there is a brief description of the content and the validating entity.

So for Type 2.1, Declaration of compliance with the order, the description is “Statement of compliance with the order” and the validating entity is the manufacturer. For Type 2.2, Test report, the description is “Statement of compliance with the order, with indication of results of nonspecific inspection.” The validating entity is again the manufacturer.

Terminology is defined in the beginning of the standard. And a chart is provided to specifically show the use of EN 10204 to support the 97/23/EC Directive. Reference is additionally made to EN 10168, Steel products – Inspection documents – List of information and description.

So, the BS EN 10204 does not describe specific requirements for any given order. The expectation is that the order itself will define the product specifications required. The document does however, define a series of document types issued by the manufacturer in which he declares that the products supplied are in compliance with the requirements of the order and in which he may supply test results if required.

The BS EN 10204 and all BS EN standards are available from Document Center Inc. at our website, www.document-center.com. Or contact us by phone at 650-591-7600, fax at 650-591-7617, or by email at info@document-center.com. Your questions and comments are welcome.